The purpose

Background:
- Carcinoembryonic antigen (CEA) is a protein present mostly in cancer cells.
- An experimental procedure developed for treating patients with cancer uses blood cells
found in their tumors or bloodstream. These cells are genetically modified using the
anti-CEA gene and a type of virus. The modified cells (anti-CEA cells) are grown in the
laboratory and then given back to the patient to try to decrease the size of the tumors.
This is called gene therapy.
Objectives:
- To determine whether advanced cancers that that express the CEA antigen can be treated
effectively with lymphocytes (white blood cells) that have been genetically engineered
to contain an anti-CEA protein.
Eligibility:
- Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond
the original site) and for whom standard treatments are not effective.
- Patients' tumors express the CEA antigen.
- Patients have the human leukocyte (HLA-A*0201) antigen.
Design:
- Workup with scans, x-rays and other tests.
- Leukapheresis to obtain cells for preparing the anti-CEA cells for later infusion.
- 1 week of chemotherapy to prepare the immune system for receiving the anti-CEA cells.
- Infusion of anti-CEA cells, followed by interleukin-2 (IL-2) treatment. The cells are
given as an infusion through a vein. IL-2 is given as a 15-minute infusion through a
vein every 8 hours for a maximum of 15 doses.
- 1-2 weeks of recovery from the effects of chemotherapy and IL-2.
- Periodic follow-up clinic visits after hospital discharge for physical examination,
review of treatment side effects, laboratory tests and scans every 1 to 6 months.

Provided treatments

Biological: PG13-CEA_TCR (Anti-CEA TCR PBL)

Drug: Aldesleukin

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Locations near you

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Full eligibility criteria for NCT00923806

Ages eligible for Study

18 Years and older

Genders eligible for Study

All

Accepts Healthy Volunteers

No

Inclusion Criteria:

Exclusion Criteria:

All locations for NCT00923806

1 locations

United States (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States, 20892

Not specified

All Locations

View full eligibility

Results

Tris trial is registered with FDA with number: NCT00923806. The sponsor of the trial is National Cancer Institute (NCI) and it is looking for 3 volunteers for the current phase.

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